Cleared Traditional

DISPETTE II

K860899 · Ulster Scientific, Inc. · Hematology
Apr 1986
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K860899 is an FDA 510(k) clearance for the DISPETTE II, a Test, Erythrocyte Sedimentation Rate (Class I — General Controls, product code JPH), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on April 14, 1986, 35 days after receiving the submission on March 10, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6700.

Submission Details

510(k) Number K860899 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1986
Decision Date April 14, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPH — Test, Erythrocyte Sedimentation Rate
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.6700